{"id":258905,"date":"2021-12-14T18:48:17","date_gmt":"2021-12-15T00:48:17","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=258905"},"modified":"2022-04-21T06:57:38","modified_gmt":"2022-04-21T11:57:38","slug":"senators-grill-robert-califf-fda-abortion-pill","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/senators-grill-robert-califf-fda-abortion-pill\/","title":{"rendered":"Senators grill FDA Commissioner nominee Robert Califf on his history of expanding abortion pill use"},"content":{"rendered":"
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On Tuesday, the U.S. Senate Committee on Health, Education, Labor and Pensions held hearings<\/a> on whether to approve Robert Califf<\/a>, President Joe Biden\u2019s nominee to head the\u00a0Food and Drug Administration (FDA). Califf previously headed the agency in 2016, when the agency\u00a0extended<\/a>\u00a0the use of the deadly abortion pill regimen to preborn babies from seven weeks up to 10 weeks.<\/p>\n

If approved,\u00a0Califf\u00a0would replace acting FDA Commissioner Janet Woodcock, who\u00a0previously<\/a>\u00a0served as Director of the FDA\u2019s Center for Drug Evaluation and Research in the years when the agency first approved the abortion pill in the U.S.<\/p>\n

“My priorities, if confirmed, would be: emergency preparedness and response; consumer and patient protection; and modernization and innovation,” Califf wrote<\/a> in his prepared statement, where he dodged the issue of abortion.<\/p>\n

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Robert Califf Dec 14, 2021 Senate hearing for FDA Commissioner asked about the abortion pill<\/p><\/div>\n

Califf’s history with FDA<\/strong><\/p>\n

Robert Califf\u00a0served<\/a>\u00a0as the Obama Administration\u2019s FDA Commissioner from 2016-2017 following his\u00a02015 nomination<\/a>.\u00a0Under Califf\u2019s leadership<\/a>, in\u00a02016<\/a>, the FDA enabled several modifications to a safety requirement for the abortion pill (Mifeprex) known as the\u00a0Risk Evaluation and Mitigation System<\/a>\u00a0(REMS),\u00a0which the\u00a0FDA<\/a>\u00a0requires \u201cfor certain medications with serious safety concerns.\u201d Only a few medications require REMS.<\/p>\n

Califf was asked about his position on the REMS, drastically loosened by the Biden Administration’s FDA during the COVID-19 pandemic. Currently, the abortion pill mifepristone (Mifeprex) and a second drug, misoprostol (Cytotec and others) used in the FDA approved regimen may be ordered online and shipped to customers by mail.<\/p>\n

For safety reasons, REMS prohibits the pill from being ordered online or in a pharmacy and limits distribution to approved facilities or hospitals which are required to properly date a woman’s pregnancy, rule out the possibility of a dangerous ectopic pregnancy, and can respond to emergencies or refer to a facility that can.<\/p>\n

Califf questioned by\u00a0Senator Richard Burr<\/strong><\/p>\n

During the hearing, North Carolina Senator Richard Burr\u00a0raised<\/a> the issue of Califf’s history with the FDA REMS on the abortion pill.\u00a0“You’ve had a history with the\u00a0the\u00a0Risk Evaluation and Mitigation System<\/a>\u00a0or REMS for the drug mifepristone,” Senator Burr stated. “Many around the country have asked that you address this issue.”<\/p>\n

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Thank you @SenatorBurr<\/a> for raising with FDA Commissioner nominee Robert Califf Americans' concerns over weakening safety requirements on dangerous chemical abortion drugs pic.twitter.com\/lr5yp94VBW<\/a><\/p>\n

— Susan B. Anthony List #ModernizeOurLaw (@SBAList) December 14, 2021<\/a><\/p><\/blockquote>\n